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A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Androgen Independent Prostate Cancer (AIPC), Non Small Cell Lung Cancer (NSCLC)

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Trial Information

A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004


This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to
monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously
enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only
subjects randomized to the DN-101 treatment arm and are currently receiving study drug
(including subjects on study suspension / holiday) will be included in the current study.
For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment
will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified
physical exam (vital signs and weight) and laboratory assessments. Modified physical exam
should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory
assessments will be performed per standard of care as noted in the labeling. DN-101-related
laboratory assessments for serum calcium and serum creatinine will be performed at the
beginning of each treatment cycle. Clinically significant abnormal laboratory values will
be reported as adverse events.


Inclusion Criteria:



- Prior participation in DN101-002 or DN101-004 studies, where the subject received at
least one dose of DN-101

- Able and willing to give written informed consent

Exclusion Criteria:

- Disease progression or unacceptable toxicity while previously enrolled in DN101-002
or DN101-004 studies

- Prior investigational therapy other than DN-101 within 30 days of enrollment

- Known hypersensitivity to calcitriol

- Pregnancy (women of childbearing potential only)

- Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

011-016

NCT ID:

NCT00285675

Start Date:

April 2006

Completion Date:

January 2008

Related Keywords:

  • Androgen Independent Prostate Cancer (AIPC)
  • Non Small Cell Lung Cancer (NSCLC)
  • Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Tyler Cancer CenterTyler, Texas  75702
Oregon Health & Science UniversityPortland, Oregon  97201
Columbia Presbyterian Medical CenterNew York, New York  10032
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
NW Kaiser Permanente PortlandPortland, Oregon  97227
Piedmont Hematology Oncology AssociatesWinston Salem, North Carolina  27103
Kaiser Permanente Medical Group, Northern CaliforniaVallejo, California  94589
Alta Bates Comprehensive CenterPortland, Oregon  97239-3098
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer CenterPittsburgh, Pennsylvania  15232-1305
Northwest Cancer Specialists Vancouver OfficeVancouver, Washington  98684